MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-15 for CASCADE EMG/EP/EEG IOM manufactured by Cadwell Industries, Inc..
[54788381]
Patient Sequence No: 1, Text Type: N, H10
[54788382]
At the end of the spinal case, the vendor noted burns at the sites of the neurostimulator electrode pins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5952204 |
| MDR Report Key | 5952204 |
| Date Received | 2016-09-15 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-04-28 |
| Report Date | 2016-09-01 |
| Date Reported to FDA | 2016-09-01 |
| Date Reported to Mfgr | 2016-09-01 |
| Date Added to Maude | 2016-09-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASCADE EMG/EP/EEG IOM |
| Generic Name | STIMULATOR, PHOTIC, EVOKED RESPONSE |
| Product Code | GWE |
| Date Received | 2016-09-15 |
| Returned To Mfg | 2016-06-23 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CADWELL INDUSTRIES, INC. |
| Manufacturer Address | 909 NORTH KELLOGG STREET KENNEWICK WA 99336 US 99336 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-15 |